Effect of Clear Aligner Wear Protocol on External Root Resorption: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Root resorption
研究概览
简要总结
The aim of this two-arm randomized clinical trial was to compare the effect of 7-day and 14-day orthodontic clear aligner wear protocols on external apical root resorption (EARR) and pain perception
详细描述
Fifty adult patients (21 Male and 29 female with a mean age of 23.7 ± 1.8) presented at the postgraduate orthodontic clinics at Jordan University of Science and Technology (JUST) were randomly allocated into a 7-day or 14-day aligner change protocol. Each patient underwent a standardized series of digital periapical radiographs (three upper and three lower). Baseline radiographs (T0) were taken before the initiation of treatment, and follow-up radiographs (T1) were collected after six months of aligner therapy.
EARR was measured from a line drawn at the cemento-enamel junction (CEJ) to the tooth's apex before treatment (T₀), and after treatment (T1), the difference in length was calculated and graded using the Malmgren Index. Pain perception was assessed using a verbal rating scale (VRS) at six-time intervals (24 hours, first week, second week, first month, third month and sixth month). Statistical analyses were used to compare pre- and post-treatment changes within and between the groups. Multiple linear regression was used to identify predictors of EARR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with complete permanent dentition except wisdom teeth
- •Participants presented with mild to moderate malocclusion (Average degree of crowding).
- •Participants with good oral hygiene and absence of periodontal disease.
- •No history of trauma or prior orthodontic treatment.
排除标准
- •Participants with thin or petite roots.
- •Participants with pre-existing root resorption
- •Participants with endodontically treated incisors or canines.
- •Participants with history of trauma to incisors teeth
- •Participants with previous orthodontic treatment.
- •Participants with periapical pathology, ankylosisor cystic lesions.
- •Participants with medical conditions that may affecting pain or inflammatory responses.
研究组 & 干预措施
7-day aligner wearing protocol
干预措施: Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocols (Other)
14-day aligner wearing protocol
干预措施: Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocols (Other)
结局指标
主要结局
Root resorption
时间窗: 6 months
Peri-apical radiographs will be taken before and after the treatment, tooth root length will be measured before and after treatment from the radiographs
次要结局
- Pain perception(After 24 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months)
